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EK Onefit Abutment

Model EKCMAHT · HIOSSEN, INC. · DI 00810125999154

NHA — Abutment, Implant, Dental, Endosseous · Class II · 21 CFR 872.3630

UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

13452019-01: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 1.67/device2019-05: 0 reports for this device; peer average 5.33/device2019-06: 0 reports for this device; peer average 2/device2019-07: 0 reports for this device; peer average 2.71/device2019-08: 0 reports for this device; peer average 2.57/device2019-09: 0 reports for this device; peer average 2.81/device2019-10: 0 reports for this device; peer average 2/device2019-11: 0 reports for this device; peer average 2.38/device2019-12: 0 reports for this device; peer average 2/device2020-01: 0 reports for this device; peer average 1.78/device2020-02: 0 reports for this device; peer average 2.22/device2020-03: 0 reports for this device; peer average 2.04/device2020-04: 0 reports for this device; peer average 2.17/device2020-06: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 1.13/device2020-08: 0 reports for this device; peer average 2.5/device2020-09: 0 reports for this device; peer average 1.79/device2020-10: 0 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 1.27/device2020-12: 0 reports for this device; peer average 1.64/device2021-01: 0 reports for this device; peer average 1.63/device2021-02: 0 reports for this device; peer average 1.56/device2021-03: 0 reports for this device; peer average 1.33/device2021-04: 0 reports for this device; peer average 1.4/device2021-05: 0 reports for this device; peer average 1.61/device2021-06: 0 reports for this device; peer average 1.46/device2021-07: 0 reports for this device; peer average 1.38/device2021-08: 0 reports for this device; peer average 1.48/device2021-09: 0 reports for this device; peer average 1.13/device2021-10: 0 reports for this device; peer average 1.38/device2021-11: 0 reports for this device; peer average 1.59/device2021-12: 0 reports for this device; peer average 2/device2022-01: 0 reports for this device; peer average 2.5/device2022-02: 0 reports for this device; peer average 1.25/device2022-03: 0 reports for this device; peer average 2.2/device2022-04: 0 reports for this device; peer average 1.65/device2022-05: 0 reports for this device; peer average 1.42/device2022-06: 0 reports for this device; peer average 1.38/device2022-07: 0 reports for this device; peer average 1.25/device2022-08: 0 reports for this device; peer average 1.27/device2022-09: 0 reports for this device; peer average 1.6/device2022-10: 0 reports for this device; peer average 1.6/device2022-11: 0 reports for this device; peer average 1.78/device2022-12: 0 reports for this device; peer average 1.83/device2023-01: 0 reports for this device; peer average 1.86/device2023-02: 0 reports for this device; peer average 1.39/device2023-03: 0 reports for this device; peer average 1.58/device2023-04: 0 reports for this device; peer average 1.36/device2023-05: 0 reports for this device; peer average 1.93/device2023-06: 0 reports for this device; peer average 1.2/device2023-07: 0 reports for this device; peer average 1.62/device2023-08: 0 reports for this device; peer average 1.35/device2023-09: 0 reports for this device; peer average 1.21/device2023-10: 0 reports for this device; peer average 1.14/device2023-11: 0 reports for this device; peer average 1.26/device2023-12: 0 reports for this device; peer average 2.18/device2024-01: 0 reports for this device; peer average 1.79/device2024-02: 0 reports for this device; peer average 1.2/device2024-03: 0 reports for this device; peer average 1.52/device2024-04: 0 reports for this device; peer average 1.32/device2024-05: 0 reports for this device; peer average 1.52/device2024-06: 0 reports for this device; peer average 1.35/device2024-07: 0 reports for this device; peer average 1.23/device2024-08: 0 reports for this device; peer average 1.07/device2024-09: 0 reports for this device; peer average 1.15/device2024-10: 0 reports for this device; peer average 2.25/device2024-11: 0 reports for this device; peer average 2.35/device2024-12: 0 reports for this device; peer average 1.08/device2025-01: 0 reports for this device; peer average 1.88/device2025-02: 0 reports for this device; peer average 1.74/device2025-03: 0 reports for this device; peer average 1.45/device2025-04: 0 reports for this device; peer average 1.88/device2025-05: 0 reports for this device; peer average 3.27/device2025-06: 0 reports for this device; peer average 1.46/device2025-07: 0 reports for this device; peer average 1.56/device2025-08: 0 reports for this device; peer average 1.67/device2025-09: 0 reports for this device; peer average 1.4/device2025-10: 0 reports for this device; peer average 2.02/device2025-11: 0 reports for this device; peer average 1.06/device2025-12: 0 reports for this device; peer average 1.41/device2026-01: 0 reports for this device; peer average 2.05/device2026-02: 0 reports for this device; peer average 1.58/device2026-03: 0 reports for this device; peer average 1.63/device2026-04: 0 reports for this device; peer average 2.23/device2026-05: 0 reports for this device; peer average 2.27/device2026-06: 0 reports for this device; peer average 4.08/device01030405060708091011120102030406070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0301
2019-0401.67
2019-0505.33
2019-0602
2019-0702.71
2019-0802.57
2019-0902.81
2019-1002
2019-1102.38
2019-1202
2020-0101.78
2020-0202.22
2020-0302.04
2020-0402.17
2020-0601
2020-0701.13
2020-0802.5
2020-0901.79
2020-1001
2020-1101.27
2020-1201.64
2021-0101.63
2021-0201.56
2021-0301.33
2021-0401.4
2021-0501.61
2021-0601.46
2021-0701.38
2021-0801.48
2021-0901.13
2021-1001.38
2021-1101.59
2021-1202
2022-0102.5
2022-0201.25
2022-0302.2
2022-0401.65
2022-0501.42
2022-0601.38
2022-0701.25
2022-0801.27
2022-0901.6
2022-1001.6
2022-1101.78
2022-1201.83
2023-0101.86
2023-0201.39
2023-0301.58
2023-0401.36
2023-0501.93
2023-0601.2
2023-0701.62
2023-0801.35
2023-0901.21
2023-1001.14
2023-1101.26
2023-1202.18
2024-0101.79
2024-0201.2
2024-0301.52
2024-0401.32
2024-0501.52
2024-0601.35
2024-0701.23
2024-0801.07
2024-0901.15
2024-1002.25
2024-1102.35
2024-1201.08
2025-0101.88
2025-0201.74
2025-0301.45
2025-0401.88
2025-0503.27
2025-0601.46
2025-0701.56
2025-0801.67
2025-0901.4
2025-1002.02
2025-1101.06
2025-1201.41
2026-0102.05
2026-0201.58
2026-0301.63
2026-0402.23
2026-0502.27
2026-0604.08
This device (reports/month)Average device in NHA (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K233389 — cites (transitively): K032455 (d1), K123627 (d1), K162390 (d1), K203360 (d1), K100245 (d2), K101096 (d2), K103537 (d2), K112532 (d2), K123471 (d2), K132219 (d2), K140934 (d2), K151626 (d2), K110308 (d2), K140507 (d2), K153332 (d2), K161689 (d2), K182091 (d2), K093352 (d3), K081575 (d3), K093889 (d3), K072363 (d3), K073070 (d3), K090237 (d3), K120822 (d3), K063341 (d3), K083633 (d3), K120847 (d3), K121585 (d3), K053088 (d3), K123784 (d3), K102436 (d3), K122171 (d3), K062051 (d3), K063861 (d3), K081786 (d3), K121995 (d3), K130662 (d3), K062030 (d3), K080594 (d3), K132067 (d3), K150295 (d3), K160519 (d3), K160670 (d3), K073465 (d4), K052272 (d4), K071548 (d4), K072055 (d4), K072151 (d4), K072569 (d4), K080195 (d4), K081005 (d4), K082764 (d4), K083550 (d4), K093113 (d4), K101465 (d4), K113283 (d4), K080387 (d4), K072679 (d4), K091678 (d4), K093027 (d4), K091208 (d4), K061176 (d4), K083067 (d4), K033922 (d4), K033984 (d4), K062129 (d4), K081419 (d4), K121131 (d4), K122855 (d4), K983742 (d4), K123755 (d4), K000100 (d4), K010073 (d4), K020646 (d4), K022562 (d4), K030463 (d4), K041509 (d4), K061410 (d4), K063286 (d4), K071370 (d4), K071638 (d4), K072878 (d4), K073075 (d4), K082639 (d4), K083496 (d4), K093321 (d4), K103089 (d4), K113779 (d4), K120414 (d4), K130222 (d4), K133991 (d4), K143022 (d4), K062509 (d4), K093708 (d4), K100152 (d4), K111421 (d4), K123664 (d4), K132209 (d4), K151324 (d4), K072896 (d4), K073247 (d4), K121843 (d4), K082213 (d5), K070478 (d5), K073268 (d5), K080396 (d5), K013867 (d5), K032158 (d5), K032448 (d5), K060880 (d5), K062493 (d5), K072642 (d5), K081666 (d5), K091756 (d5), K041236 (d5), K090069 (d5), K014235 (d5), K060958 (d5), K061629 (d5), K073345 (d5), K980549 (d5), K080286 (d5), K082545 (d5), K063779 (d5), K103252 (d5), K072624 (d5), K083805 (d5), K091239 (d5), K101005 (d5), K101849 (d5), K120338 (d5), K974738 (d5), K980698 (d5), K003271 (d5), K003552 (d5), K012757 (d5), K142890 (d5), K070833 (d6), K042658 (d6), K043042 (d6), K061477 (d6), K072856 (d6), K120053 (d6), K072071 (d7) — cited as predicate by K260555

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — HIOSSEN, INC.

  • Warning Letter 2012-10-05 Hiossen Inc.
  • Warning Letter 2012-10-05 Hiossen Inc.
  • VAI 2025-07-23 Hiossen Inc. · 1 citations
  • VAI 2025-07-23 Hiossen Inc. · 1 citations
  • NAI 2017-04-24 Hiossen Inc. · 0 citations
  • NAI 2017-04-24 Hiossen Inc. · 0 citations
  • VAI 2017-04-12 Hiossen Inc. · 2 citations
  • VAI 2017-04-12 Hiossen Inc. · 2 citations
  • VAI 2013-04-18 Hiossen Inc. · 0 citations
  • VAI 2013-04-18 Hiossen Inc. · 0 citations
  • OAI 2012-05-16 Hiossen Inc. · 0 citations
  • OAI 2012-05-16 Hiossen Inc. · 0 citations